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临床试验/NCT02044900
NCT02044900已完成不适用

Polysomnography and Heart Rate Indexes in Obstructive Sleep Apnea

Ovidiu Constantin Baltatu1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Polysomnography indexes

研究概览

简要总结

The purpose of this study is to evaluate the diagnostic accuracy of polysomnography indexes for diagnosis of sleep apnea in human subjects obstructive sleep apnea (OSA). This includes evaluation of polysomnography indexes (AHI; AI, arousal index; ODI, oxygen desaturation index) and heart rate variability (HRV) indexes.

详细描述

This is a cross-sectional study collecting data from patients from the Sleep Institute of Itaperuna, Rio de Janeiro, Brazil. Polysomnography (PSG) monitoring and diagnosis was in accordance with American Society of Sleep Medicine (ASSM) standards. Standard baseline polysomnography is performed using a computerised system. The following extracted signals are measured: 2 electroencephalogram channels (O1-A2, O2-A1, C3-A2, C4-A1), 2 electrooculogram channels, electromyography (EMG, bilateral anterior tibialis), pulse oximetry (arterial oxygen saturation), nasal-oral airflow (thermistors), and electrocardiogram (ECG derivation DII). The polysomnograms are scored according to the criteria of Rechtschaffen and Kales.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Diagnosis of obstructive sleep apnea with an apnea-hypopnea index (AHI) > 5.

排除标准

  • Subjects with a history or clinical examination suggestive of neuromuscular disease, hypertension or any surgical treatment were not considered in the study.

结局指标

主要结局

Polysomnography indexes

时间窗: one night

Polysomnography indexes and full-length sleep ECG recordings are extracted from polysomnogram measurements.

次要结局

未报告次要终点

研究者

发起方
Ovidiu Constantin Baltatu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ovidiu Constantin Baltatu

Professor

Universidade Camilo Castelo Branco

研究点 (1)

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